Arterial chemo combo shows promise in stomach cancer trial
NCT ID NCT05593458
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 3 trial tests whether giving chemotherapy directly into the artery (instead of through a vein) along with immunotherapy can better shrink locally advanced stomach cancer before surgery. About 190 participants will receive either the standard chemo regimen or the arterial infusion approach, followed by surgery and additional treatment. The study aims to see if the new method leads to higher rates of tumor clearance and better long-term survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Oxaliplatin, S-1, and Sintilimab (PD-1 antibody)
- What this could lead to
- If this works, it could offer a more effective way to shrink gastric tumors before surgery, potentially improving survival and reducing recurrence.
- What could go wrong
- This is a mid-stage trial with only 190 participants, so results may not apply to everyone. Arterial infusion carries risks like bleeding or infection, and the added benefit over standard therapy is not yet proven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 190 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2023
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Eastern Cooperative Oncology Group(ECOG) score 0-1 * Ambulatory males or females, aged 18-75 years * Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (Siewert type II or III) * Locally advanced gastric carcinoma (cT3N2-3M0, cT4aN1-3M0, cT4bNanyM0, American Joint Committee on Cancer (AJCC) TNM staging system 8th edition) * Life expectancy more than 3 months * Give written informed consent, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice. * Normal hepatic, renal, and bone marrow function (ALT/AST\<2.5 fold of upper limit value;Tbil\<1.5mg/dl, Cr\<1.5 fold of upper limit value; White Blood Cell count≥3 × 10\^9/L, ANC ≥ 1.5 × 10\^9/L,PLT≥ 80 × 10\^9/L,Hb ≥ 90 g/L). Exclusion Criteria: * Patients can not bear surgical procedure. * Pregnant or lactating women. * HER2 overexpression(+++) confirmed by immunohistochemistry. * Previous cytotoxic chemotherapy, radiotherapy or immunotherapy. * History of another malignancy within the last five years. * History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the Investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake. * Clinically significant (i.e. active) cardiac disease e.g. symptomatic coronary artery disease, New York Heart Association (NYHA) grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication or myocardial infarction within the last 12 months. * History of dysphagia, complete or partial gastrointestinal obstruction, active gastrointestinal bleeding and gastrointestinal perforation; * Organ allografts requiring immunosuppressive therapy. * Serious uncontrolled intercurrent infections or other serious uncontrolled concomitant disease. * Moderate or severe renal impairment: serum creatinine \> 1.5 x upper limit of normal (ULN). * Hypersensitivity to any drug of the study regimen. * With abdominal cavity implantation metastasis or distant metastasis. * Unwilling or unable to comply with the protocol for the duration of the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Gastrointestinal Department of Second Affiliated Hospital of Zhejiang University
RECRUITINGHangzhou, Zhejiang, 310000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Dual immunotherapy plus chemo before surgery: a new way to shrink stomach tumors?
- Can immunotherapy wipe out stomach cancer before surgery?
- New drug cocktail aims to fight Hard-to-Treat stomach cancers
- New triple therapy aims to shrink stomach tumors before surgery
- Immunotherapy duo aims to shrink stomach tumors before surgery
- Could blood pressure pills boost stomach cancer treatment?